Sr. Specialist, QA CMO
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
This is an individual contributor position in the QA CMO Core team. The individual is expected to perform routine job functions with minimal supervision. The Core group functions to actively support the QA CMO department (Commercial, Clinical, and Small Molecule groups). The QA CMO Sr. Specialist is expected to communicate well with QA, Quality Control, Supply Chain, Materials Management, Regulatory, and CMO both at BioMarin and external CMOs.
- Review shipment temperature data to issue Certificates of Compliance, Certificates of Compliance for Further Processing, and temperature approvals for timely drug release
- Provide Supply Chain oversight and manage shipment-related deviation lifecycle.
- Provide oversight of temperature review and temperature excursion SOPs.
- Transact approved lots within Oracle EBS.
- Track ID samples through LabWare LIMS, for use in ID and product stability testing.
- Contribute group release data to commercial and clinical lot release trackers.
- Monitor TrackWise PRs (Quality Events, Deviations, Change Requests, and CAPAs) and follow-up with individuals weekly to progress records ensuring timely closures.
- Regularly extract data from TrackWise for generation of QA CMO metrics.
- Scan, organize, and archive released records for electronic storage on Office365.
- Manage storage and archival of physical batch records.
- Perform Cycle Counts weekly for backlog and work completed.
- Perform gap analysis on Quality Technical Agreements (QTA) and publish/retire finished documents using the internal electronic document management system (EDMS).
- Create and route product specification documents, following MAA/BLA/CTA/IND/IMPD filings provided by Regulatory Affairs
- Open and set-up Change Requests records for product specification documents.
- Create manual Certificates of Analysis, as needed.
- Manage and maintain the CMO Scorecard process.
- Ensure all individual training and group-specific guidelines are kept current.
- Assist with regulatory and internal inspections, as needed
- 2-5 years of experience
- Strong organizational and communication skills required
- Proficiency with computer systems – Microsoft Office Suite
- 2 years of experience in a QA/Compliance/Regulatory setting
- Proficiency with TrackWise or QMS, LIMS, Oracle, EDMS, and Office365
BS in a technical science field
WORK ENVIRONMENT/PHYSICAL DEMANDS
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.